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The Rise and Pitfalls of Oxycontin ®

Put together a powerful new class of prescription painkillers, a burgeoning movement to liberalize the use of narcotics for pain, and an aggressive pharmaceutical marketing campaign, and you have the ingredients of the public-health disaster described in New York Times reporter Barry Meier's new book, Pain Killer: A "Wonder" Drug's Trail of Addiction and Death (Rodale, 2003) which tracks the emergence of Oxycontin ® as a major drug of abuse in the U.S.

Federal regulators, notably the Drug Enforcement Administration, have long kept close tabs on Schedule II narcotic drugs, leading many doctors to avoid prescribing the most powerful painkillers even to terminally ill patients out of fear of addiction, diversion or -- for themselves -- prosecution. That prompted a backlash by patients' advocates who, aided by pharmaceutical companies like Purdue Pharma, began calling loudly for broader use of narcotics for patients with severe and chronic pain.

As this movement began picking up speed in the mid-1990s, Purdue Pharma introduced Oxycontin ®, based on the same drug, oxycodone, as familiar medications like Percocet and Percodan, but at exponentially higher doses and purity. "In terms of narcotic firepower, Oxycontin ® was a nuclear weapon," writes Meier. But Oxycontin ® also had a time-released mechanism which the manufacturer claimed would make the drug less appealing to drug abusers -- a claim that would later be endorsed by the Food and Drug Administration.

In his book, Meier shows that as early as 1999, Purdue Pharma began receiving anecdotal reports that addicts were getting around the time-release mechanism by crushing Oxycontin ® tablets and snorting them to get a potent high from a drug that is pure oxycodone. Yet the company continued to aggressively market Oxycontin ® to doctors as less likely to be abused than other narcotic drugs, as well as expanding the market for Oxycontin ® beyond severe- and chronic-pain patients for use with a wider range of conditions, including lower-back pain, arthritis, and pain resulting from sports injuries and trauma.

Meier finds no "black hats" in his examination. But he questions why Purdue Pharma took so long to take serious steps to address Oxycontin ® abuse.

By 1999 and 2000, rural communities in Virginia and Maine were reporting widespread abuse of Oxycontin ®. In late 2000, Lee County, Va., physician Art Van Zee wrote to Purdue Pharma asking the company to stop marketing the drug for nonmalignant pain and warn doctors about its potential for abuse. Later, Van Zee would call for Oxycontin ® -- which was bringing in more than $1 billion annually to Purdue Pharma -- to be pulled off the market altogether.

But Purdue didn't inform doctors about the problems with Oxycontin ® until mid-2001, and continued to market the drug broadly for treatment of all kinds of pain. "I think they were understandably reluctant to take the drug off the market ... nor would I advocate taking it off the market," Meier said in an interview with Join Together. "But were there steps that Purdue could have taken more quickly to help prevent this problem from growing in scope and intensity? I think yes."

Still, there's plenty of blame to go around. Meier is highly critical of the FDA for approving a label for Oxycontin ® (later rescinded) implying that the drug would be less prone to abuse or diversion than other narcotics. "That was a major screwup on FDA's part," he says. With its focus on illicit drugs, DEA was slow to recognize the abuse potential of powerful narcotics like Oxycontin ®. Unscrupulous or unqualified doctors overprescribed the medication and fed the illegal market for the drug.

Pain-management advocates also shared responsibility for the problem, Meier said. "They had labored in the wilderness for so long that they constantly downplayed the risks," worrying that controversy about Oxycontin ® could hurt their progress in getting proper pain medication to suffering patients.

"The ultimate tragedy of the Oxycontin ® episode was that it didn't have to happen; at least not in the way it unfolded," writes Meier in Pain Killer. "But pain-management advocates, drug-company executives, regulators, and law-enforcement officials blindly marched forward, venturing ever deeper into one of medicine's most chaotic realms, the pain industry -- an industry that, much like pain itself, defies simple definition or description."

Meier's investigation ultimately reveals that Purdue Pharma used questionable science to back up its claims about the low risk of Oxycontin ® abuse, and strongly hints that the profit motive may have gotten in the way of sensible marketing of the product. "It was somewhere around the mid-1990s, as the height of the pain-management movement and marketing of Oxycontin ® converged, that the boundary lines between "severe" pain and "moderate" pain, "chronic" pain and "acute" pain, blurred and became lost," writes Meier. "It is hard to believe, despite Purdue's arguments to the contrary, that this broadening availability of Oxycontin ®, a drug classified as the most potentially addicting medication legally available, along with the minimizing of its abuse potential, did not play a crucial role in setting the stage for the disaster that followed."

Unlike some other critics, Meier gives Purdue Pharma credit for the campaigns it has launched in the past few years to educate physicians and others about Oxycontin ®'s potential for abuse. He praises the company for working with state officials in Florida and elsewhere to push for comprehensive prescription-monitoring systems -- initiatives that have been opposed by both doctors' group and other pharmaceutical companies -- and says reformulating the drug to include naloxone -- which inhibits the "high" associated with drugs like oxycodone -- could limit abuse. "What Purdue has done has been, in large part, worthwhile," Meier says.

"There's no evidence that Purdue knew that Oxycontin ® would become the hottest drug on the street," adds Meier, though he points out, "We still don't know the real story of what happened inside Purdue, since those documents are not in the public forum."

Meier is careful not to discount the benefits that Oxycontin ® has had for patients suffering severe or chronic pain. And he says that some positives have emerged from the Oxycontin ® debacle, particularly a heightened awareness of the problem of prescription-drug abuse.

"Whether there are still efforts going on to minimize or trivialize these drugs, I think there's widespread recognition that changes have to be made, and changes are being made in how drugs like these are presented to doctors," he told Join Together. "These drugs do need to get to patients, but they need to be kept only for the worst-suffering patients."

Source: www.jointogether.org